510(k) · Cleared
ClearedTechCare Trauma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milvue · QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Cleared on Jan 17, 2025 as substantially equivalent to K222176 (Gleamer, 2023) after a 177-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Jan 17, 2025
- Review
- 177 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN180005 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QBS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QBS device
- #1 K260378 Rayvolvescore 15.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222176 | BoneViewSummary page 7…: Regulation: 21 CFR 892.2090 Regulatory Class: Class II Product Code: QBS 3. Predicate Device Trade Name: BoneView 1.1-US Manufacturer: Gleamer 510(k) reference: K222176 Classification Name: Radiological computer assisted detection/diagnosis software for fracture Regulatory Class: Class II… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QBS devicesQBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QBS
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QBS
123in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBS
No recall names QBS since 2007.
Adverse event reports per year · QBS
No MAUDE report names QBS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 123 | 0 | — |
What is it indicated for?
TechCare Trauma is intended to analyze 2D X ray radiographs using machine learning techniques to aid in the detection, localization, and characterization of fractures and/or elbow joint effusion during the review of commonly acquired radiographs of: TechCare Trauma can provide results for fracture in neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).…
Read the full statement (175 words)
TechCare Trauma is intended to analyze 2D X ray radiographs using machine learning techniques to aid in the detection, localization, and characterization of fractures and/or elbow joint effusion during the review of commonly acquired radiographs of:
TechCare Trauma can provide results for fracture in neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).
TechCare Trauma can provide results for elbow joint effusions in children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).
The intended users of TechCare Trauma are clinicians with the authority to diagnose fractures and/or elbow joint effusions in various settings including primary care (e. g., family practice, internal medicine), emergency medicine, urgent care, and specialty care (e. g. orthopedics), as well as radiologists who review radiographs across settings.
TechCare Trauma results are not intended to be used on a stand-alone basis for clinical decision-making. Primary diagnostic and patient management decisions are made by the clinical user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242171: TechCare Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242171
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026